21 CFR 312.55 - Informing investigators.

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There is 1 rule appearing in the Federal Register for 21 CFR 312. View below or at eCFR (GPOAccess)
§ 312.55 Informing investigators.
(a) Before the investigation begins, a sponsor (other than a sponsor-investigator) shall give each participating clinical investigator an investigator brochure containing the information described in § 312.23(a)(5).
(b) The sponsor shall, as the overall investigation proceeds, keep each participating investigator informed of new observations discovered by or reported to the sponsor on the drug, particularly with respect to adverse effects and safe use. Such information may be distributed to investigators by means of periodically revised investigator brochures, reprints or published studies, reports or letters to clinical investigators, or other appropriate means. Important safety information is required to be relayed to investigators in accordance with § 312.32.
[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9586, Mar. 4, 2002]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2015-02-10; vol. 80 # 27 - Tuesday, February 10, 2015
    1. 80 FR 7318 - Individual Patient Expanded Access Applications: Form FDA 3926; Draft Guidance for Industry; Availability
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of draft guidance.
      February 10, 2015. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 13, 2015. Submit either electronic or written comments concerning the collection of information proposed in the draft guidance by April 13, 2015.
      21 CFR Part 312

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 312 after this date.

  • 2015-02-10; vol. 80 # 27 - Tuesday, February 10, 2015
    1. 80 FR 7318 - Individual Patient Expanded Access Applications: Form FDA 3926; Draft Guidance for Industry; Availability
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of draft guidance.
      February 10, 2015. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 13, 2015. Submit either electronic or written comments concerning the collection of information proposed in the draft guidance by April 13, 2015.
      21 CFR Part 312